Director of Engineering, Facilities, and Validation
Location: Somerville, Massachusetts, 02143, United States
Finch Therapeutics is a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery platform to develop a novel class of orally administered biological drugs.
With the capabilities to develop both complete and targeted microbiome therapeutics, Finch is advancing a rich pipeline of candidates designed to address a wide range of unmet medical needs. Finch’s lead candidate, CP101, is in late-stage clinical development for recurrent C. difficile infection (CDI). In June 2020, Finch announced that CP101 met its primary efficacy endpoint in PRISM3, the first of two pivotal trials to support the development of CP101 for the prevention of recurrent CDI. Finch is also developing CP101 for chronic hepatitis B, and FIN-211 for autism spectrum disorder. In partnership with Takeda, Finch is advancing FIN-524 and FIN-525 for ulcerative colitis and Crohn’s disease, respectively.
The Director of Engineering, Facilities and Validation, will report to the Executive Vice President, Manufacturing & Development, and will work closely with the Senior Director of Manufacturing. With guidance from the EVP, Manufacturing & Development, the incumbent will manage the design, planning, construction and maintenance of several GMP facilities, including equipment and systems. The incumbent will work with the team to build and implement documentation and systems to ensure a successful pre-licensure inspection. The incumbent will also support day-to-day manufacturing and quality lab operations by overseeing maintenance and ensuring continued compliance to cGxPs and will provide oversight for plant and equipment engineering functions.
Responsibilities / Duties
- Establish vision for Engineering, Facilities and Validation group, providing hands-on leadership and development of staff members; oversees execution of Facility/Engineering/Validation/Calibration Operations.
- Recruit and build team responsible for Site Engineering, Facilities, Validation and Calibration.
- Develop and lead site services with accountability for execution of site capital projects, process control automation, plant maintenance and site maintenance to enable Finch Therapeutics operations and other support functions to meet or exceed business expectations in cost, quality, compliance, safety, and culture.
- Maintain up to date records for all state, federal, and local licenses and inspections and maintain systems in compliance with local and state regulatory bodies associated with wastewater, sewer, emissions, waste handling/storage and disposal.
- Participate in facility design team meetings and provide visibility to senior management on progress and timelines. Manage general contractor and quality of build.
- Develop, implement and maintain system/program for cGxP equipment maintenance and calibration; generate and revise SOPs, deviations and change controls associated with Facilities’ systems.
- Manage calibration, preventative and corrective maintenance of all GMP equipment, lab equipment, and building support utilities either directly or indirectly through contractor management; utility systems inclusive of but not limited to compressed gases, HVAC systems, electrical, life safety, and emergency power system (UPS).
- Plan and manage all aspects of engineering activities and projects within the organization, ensuring engineering projects, initiatives, and processes are in conformance with organization’s established policies and best engineering practices and methods.
- Degree in engineering related field, or equivalent experience in science or manufacturing management, or a combination of education and industry experience.
- 12+ years of experience in a regulated environment, with 7+ years of Facility maintenance or Engineering experience.
- 5+ years of experience managing teams.
- Professional Engineer (PE) a plus.
- Direct experience working on large scale mechanical systems (HVAC/Refrigeration).
- Experience and demonstrated proficiency in global GxPs, industry guidance (ICH, CFR) and compliance with the same.
- Experience in Cleanroom Design, Operation and Maintenance.
- Experience setting up and/or maintaining Calibration and Validation programs in consultation with Quality.
- Knowledge of local and state regulatory requirements related to wastewater, emissions, sewer systems, waste handling/storage and disposal.
- Strong technical writing and presentation skills; Ability to work independently, with minimal supervision.
Physical demands and work environment: The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to gown and gain entry to manufacturing areas.
- Ability to work in a manufacturing clean room for extended period of time.
- Physical demands: While performing duties of job, employee is occasionally required to stand for extended periods of time as well as occasionally required to walk, sit, bend down/ crouch, use hands to handle or feel objects, tools, or controls; reach with hands and arms; talk and hear. Employee must occasionally lift and/or move up to 50 pounds.
- Work environment: Work will be performed in both an office and laboratory/ manufacturing facility. The noise level in the office is low. The noise level in the laboratory/ manufacturing facility is moderate.
More About Finch
Here at Finch, we strive to create the best work environment and experience for you through our formal benefits programs and fringe perks. Together, we hope that we’ll create a fun & supportive environment in and out of the workplace as we strive to create a new class of therapeutics together to help patients.
- Our formal benefits include medical, dental, and vision coverage through Harvard Pilgrim in addition to life insurance and long-term & short-term disability policies. We offer discretionary and flexible paid time off policies. Should you choose to start or grow your family while working at Finch, we aspire to lead our peers by offering several months of paid parental leave. We also offer a generous non-discretionary 401K contribution to help teammates save for life beyond Finch in the future and other savings and investment opportunities.
- We also try to keep the workplace an inspiring and motivating place to work with our fringe perks. Our facilities in Somerville, MA* include an in-office gym with a shower and towel service, fully stocked kitchen with free snacks, iced coffee & flavored/sparkling waters on tap, and highly subsidized meals through LeanBox. We sponsor ride-sharing to and from the office from preset locations around Boston, Cambridge, and Somerville. We are always evaluating our fringe perks and hope to grow them alongside our team.
*Only facility-dependent employees are working on-site in Somerville until further notice.
Equal Opportunity Employer
We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. Finch will make reasonable accommodations for qualified individuals with disabilities, in accordance with applicable law.